Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine (GSK3878858A) When Administered to Healthy Adults (Dose-escalation) and to Adults 18 to 64 Years of Age With a Recent S. Aureus Skin and Soft Tissue Infection (SSTI)

Summary

The study evaluates the safety, immunogenicity, and efficacy of the GSK S. aureus candidate vaccine (GSK3878858A) when administered to two groups: healthy adults (dose-escalation phase) and adults aged 18 to 64 years with a recent S. aureus skin and soft tissue infection (SSTI). In the dose-escalation safety lead-in phase, the safety and immunogenicity of four different vaccine compositions are assessed in healthy adults. Once safety has been established in this phase, the second phase, known as the proof of principle (PoP) phase, will assess the safety, immunogenicity, and efficacy of the final vaccine composition in adults with a recent SSTI.

Timeline

Start

2022-11-16

Primary completion

2024-03-12

Completion

2024-03-12

Publications

• Athan E, Greenberg RN, Baker DA, Shah R, Dubhashi S, Badat A, Thurlow C, Schlessinger J, Wronski A, Zakrzewski M, Turner D, Bindi I, Basile V, Galletti B, Spensieri F, Brazzoli M, Zigon G, Cilio GL, Ranzato G, Lattanzi M, Pellegrini M; Staph aureus 208833 study group. Safety, Efficacy, and Immunogenicity of a Multivalent Adjuvanted S. aureus Vaccine in Adults with Recent Skin And Soft Tissue Infections: An Observer-blind, Randomized, Placebo-controlled, Multinational Phase 1/2 Trial. Clin Infect Dis. 2026 Mar 9:ciag162. doi: 10.1093/cid/ciag162. Online ahead of print.

Drugs

Indications